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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Washer, Bolt Nut
510(k) Number K212990
Device Name Acumed Ankle Syndesmosis Repair System
Applicant
Acumed, LLC
5885 NE Cornelius Pass Rd.
Hillsboro,  OR  97124
Applicant Contact Janki Bhatt
Correspondent
Acumed, LLC
5885 NE Cornelius Pass Rd.
Hillsboro,  OR  97124
Correspondent Contact Janki Bhatt
Regulation Number888.3030
Classification Product Code
HTN  
Subsequent Product Codes
HTW   LXH  
Date Received09/20/2021
Decision Date 01/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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